Investigative Headgear With CPAP Mask

April 16, 2019 updated by: Fisher and Paykel Healthcare
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand, 2013
        • Fisher & Paykel Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AHI≥5 from the diagnostic night
  • ≥18 years of age
  • Prescribed CPAP or Bilevel therapy for OSA
  • Existing CPAP mask users

Exclusion Criteria:

  • Inability to give informed consent
  • Patient intolerant to PAP
  • Anatomical or physiological conditions making PAP therapy inappropriate
  • History of respiratory disease or CO2 retention.
  • Pregnant or think they may be pregnant
  • Investigated by Land Transport Safety Authority

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Headgear
Investigative Headgear with CPAP Mask.
Device: Headgear
Investigative Headgear with CPAP Mask.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants perception of the headgear on mask performance
Time Frame: 2-4 weeks
Assess if the headgear with mask changes the perception of the performance of the mask.
2-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that choose this Headgear over their usual.
Time Frame: 2-4 weeks
Assess the acceptability of the headgear with mask.
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Bhavi Ogra, BSc, Clinical Research Scientist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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